Clinical Trials

Blisters are a very common complaint in both the general population and also the athlete.
This study's aim is to determine whether applying paper tape (an inexpensive and common
component of most foot care kits) to the foot of endurance runners prevents the frequency and
severity of friction blisters.

Stanford is currently not accepting patients for this trial.For more information, please contact Grant Lipman, (650) 725 - 9445.

A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are
used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.
The ability of these to cool a person has never been quantified, the efficiency and extent of
cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of
this study is to determine whether strategically placed chemical ice packs will provide
benefit to individuals subjected to heat stress.

Friction foot blisters are one of the most common and often debilitating complaints of all
athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor
hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether
applying paper tape to the areas of the foot where blisters historically occur in endurance
runners can prevent the incidence of friction blisters.

Stanford is currently not accepting patients for this trial.For more information, please contact Grant S Lipman, MD, 415-290-9286.

This study is designed to be the first to examine the novel drug budesonide for prevention of
acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent to
high altitude. The investigators will accomplish these objectives with a prospective, double
blinded view of a large population of hikers who are ascending at their own rate in a true
hiking environment.

Stanford is currently not accepting patients for this trial.For more information, please contact Grant S Lipman, MD, 415-290-9286.

This is a research study on Altitude Illness. From the information collected and studied in
this project we hope to learn more about Altitude Illness, including factors that may affect
and prevent the development and progression of this condition. We hope to learn if the
commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude
illness. Possible participants in this study are healthy adults who indicated they would like
to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford
University researchers hope to enroll about 100 participants.

Stanford is currently not accepting patients for this trial.For more information, please contact Grant Lipman, (650) 723 - 6576.

The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory
drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated
hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over
whether NSAID ingestion during endurance events contributes to acute kidney injury. Endurance
events often ignite a "perfect storm" of physiologic insults- heat stress, dehydration, and
myopathy- which can all negatively impact kidney function. There is a concern that NSAIDs may
further potentiate these negative effects as well as contribute to EAH through its
anti-diuretic affect. To date, no powered, prospective study has ever examined the effects of
NSAIDs on either of these two biochemical outcomes
Ultramarathon endurance events, defined as any race longer than a marathon (26.2 miles), are
increasing in popularity, with a 10% increase in annual participants, and more than 69,000
finishers worldwide in 2013. Considerable literature has documented alterations in serum
biochemical profiles of these endurance athletes, with consistent evidence of elevated serum
creatinine (Cr) levels in healthy race finishers as well as those seeking medical care. While
acute renal failure in ultramarathon runners is a rare occurrence, acute kidney injury is
common, ranging from 34% in a single-stage ultramarathon to 55-80% in multi-stage
ultramarathons. The evidence is equivocal regarding NSAID ingestion and AKI. One study showed
that runners who ingested NSAIDs prior to marathons had greater post-race creatinine levels
than matched controls as well as higher rates of hospitalization and acute renal failure.
However, this contrasts with several other studies that showed a marked lack of difference in
creatinine levels or development of acute kidney injury between NSAID users and non-users
during ultramarathons. The only randomized trial to date on this subject found no difference
in serum creatinine levels between the NSAID and placebo groups at ultramarathon race end,
however conclusions were limited by a small unpowered sample size.
Exercise associated hyponatremia (EAH), defined as a serum sodium concentration below
135mEq/L, is recognized as a relatively common issue in endurance running events. The
incidence of EAH varies depending upon the distance of the race, with reported values of
3-28% for marathons, 23 - 38% for triathlons and 4-51% in single-stage ultramarathons. EAH is
likely under-diagnosed as athletes are often asymptomatic. While EAH most often manifests as
non-specific symptoms such as nausea, vomiting, dizziness, and fatigue, it can be a
potentially fatal disease that can progress to encephalopathy, seizures, pulmonary edema, and
death. There have been no large prospective studies examining the relationship between EAH
and NSAID ingestion.

Abstract

To determine whether paper tape prevents foot blisters in multistage ultramarathon runners.Multisite prospective randomized trial.The 2014 250-km (155-mile) 6-stage RacingThePlanet ultramarathons in Jordan, Gobi, Madagascar, and Atacama Deserts.One hundred twenty-eight participants were enrolled: 19 (15%) from the Jordan, 35 (27%) from Gobi, 21 (16%) from Madagascar, and 53 (41%) from the Atacama Desert. The mean age was 39.3 years (22-63) and body mass index was 24.2 kg/m (17.4-35.1), with 31 (22.5%) females.Paper tape was applied to a randomly selected foot before the race, either to participants' blister-prone areas or randomly selected location if there was no blister history, with untaped areas of the same foot used as the control.Development of a blister anywhere on the study foot.One hundred six (83%) participants developed 117 blisters, with treatment success in 98 (77%) runners. Paper tape reduced blisters by 40% (P < 0.01, 95% confidence interval, 28-52) with a number needed to treat of 1.31. Most of the study participants had 1 blister (78%), with most common locations on the toes (n = 58, 50%) and heel (n = 27, 23%), with 94 (80%) blisters occurring by the end of stage 2. Treatment success was associated with earlier stages [odds ratio (OR), 74.9, P < 0.01] and time spent running (OR, 0.66, P = 0.01).Paper tape was found to prevent both the incidence and frequency of foot blisters in runners.

Abstract

The Wilderness Medical Society (WMS) convened an expert panel to develop a set of evidence-based guidelines for the recognition, prevention, and treatment of heat-related illness. We present a review of the classifications, pathophysiology, and evidence-based guidelines for planning and preventive measures as well as best-practice recommendations for both field- and hospital-based therapeutic management of heat-related illness. These recommendations are graded based on the quality of supporting evidence and the balance between the benefits and risks or burdens for each modality.

Abstract

Acute mountain sickness occurs in more than 25% of the tens of millions of people who travel to high altitude each year. Previous studies on chemoprophylaxis with nonsteroidal anti-inflammatory drugs are limited in their ability to determine efficacy. We compare ibuprofen versus placebo in the prevention of acute mountain sickness incidence and severity on ascent from low to high altitude.Healthy adult volunteers living at low altitude were randomized to ibuprofen 600 mg or placebo 3 times daily, starting 6 hours before ascent from 1,240 m (4,100 ft) to 3,810 m (12,570 ft) during July and August 2010 in the White Mountains of California. The main outcome measures were acute mountain sickness incidence and severity, measured by the Lake Louise Questionnaire acute mountain sickness score with a diagnosis of ? 3 with headache and 1 other symptom.Eighty-six participants completed the study; 44 (51%) received ibuprofen and 42 (49%) placebo. There were no differences in demographic characteristics between the 2 groups. Fewer participants in the ibuprofen group (43%) developed acute mountain sickness compared with those receiving placebo (69%) (odds ratio 0.3, 95% confidence interval 0.1 to 0.8; number needed to treat 3.9, 95% confidence interval 2 to 33). The acute mountain sickness severity was higher in the placebo group (4.4 [SD 2.6]) than individuals receiving ibuprofen (3.2 [SD 2.4]) (mean difference 0.9%; 95% confidence interval 0.3% to 3.0%).Compared with placebo, ibuprofen was effective in reducing the incidence of acute mountain sickness.

Abstract

To compare the effectiveness of arteriovenous anastomosis (AVA) vs heated intravenous fluid (IVF) rewarming in hypothermic subjects. Additionally, we sought to develop a novel method of hypothermia induction.Eight subjects underwent 3 cooling trials each to a core temperature of 34.8±0.6 (32.7 to 36.3°C [mean±SD with range]) by 14°C water immersion for 30 minutes, followed by walking on a treadmill for 5 minutes. Core temperatures (?tes) and rates of cooling (°C/h) were measured. Participants were then rewarmed by 1) control: shivering only in a sleeping bag; 2) IVF: shivering in sleeping bag and infusion of 2 L normal saline warmed to 42°C at 77 mL/min; and 3) AVA: shivering in sleeping bag and circulation of 45°C warmed fluid through neoprene pads affixed to the palms and soles of the feet.Cold water immersion resulted in a decrease of 0.5±0.5°C ?tes and 1±0.3°C with exercise (P < .01); with an immersion cooling rate of 0.9±0.8°C/h vs 12.6±3.2°C/h with exercise (P < .001). Temperature nadir reached 35.0±0.5°C. There were no significant differences in rewarming rates between the 3 conditions (shivering: 1.3±0.7°C/h, R(2) = 0.683; IVF 1.3±0.7°C/h, R(2) = 0.863; and AVA 1.4±0.6°C/h, R(2) = 0.853; P = .58). Shivering inhibition was greater with AVA but was not significantly different (P = .07).This study developed a novel and efficient model of hypothermia induction through exercise-induced convective afterdrop. Although there was not a clear benefit in either of the 2 active rewarming methods, AVA rewarming showed a nonsignificant trend toward greater shivering inhibition, which may be optimized by an improved interface.

Abstract

Adventure sports events consist of a combination of two or more endurance disciplines, such as orienteering, running, and rock climbing, that range from a day's to a week's duration. No studies have examined acute kidney injury (AKI) in adventure sports athletes.To describe the prevalence of AKI in participants in the Endeavor Team Challenge, a 30-hour, 40-mile adventure race.In this prospective observational study, body weights were recorded at race registration. At the finish line, blood sample results by point-of-care testing and weights were recorded. Changes in serum creatinine (Cr) from an estimated baseline value and severity of AKI were calculated, with "risk of injury" defined as 1.5 x baseline Cr, and "injury" defined as 2 x baseline Cr. These two categories of AKI were combined to calculate the total prevalence. Results: There were 88 enrolled study participants with complete data available on 46 (52%). The mean age of those enrolled in the study was 36.8 years (+/- 7.7), 90% were males, and body mass index (BMI) was 25.7 kg/m(2) (+/- 2.4). Of the competitors who completed the study, 34 (73%) had some degree of AKI, with 27 (58%) found to be at "risk" and seven (15%) with "injury". There was a significant correlation between weight loss and elevated Cr (r = -0.29, p = 0.047), with a trend towards nonsteroidal anti-inflammatory drug (NSAID) use being correlated with AKI (p = 0.058). Acute kidney injury was observed in the majority of the Endeavor Team Challenge adventure racers, similar to what has been observed in multistage ultramarathons, and greater than after standard marathons and single-stage ultramarathons.

Abstract

To test whether the 6-minute walk test (6MWT), including postexercise vital sign measurements and distance walked, predicts summit success on Denali, AK.This was a prospective observational study of healthy volunteers between the ages of 18 and 65 years who had been at 4267 m for less than 24 hours on Denali. Physiologic measurements were made after the 6MWT. Subjects then attempted to summit at their own pace and, at the time of descent, completed a Lake Louise Acute Mountain Sickness Questionnaire and reported maximum elevation reached.One hundred twenty-one participants enrolled in the study. Data were collected on 111 subjects (92% response rate), of whom 60% summited. On univariate analysis, there was no association between any postexercise vital sign and summit success. Specifically, there was no significant difference in the mean postexercise peripheral oxygen saturation (Spo2) between summiters (75%) and nonsummiters (74%; 95% CI, -3 to 1; P = .37). The distance a subject walked in 6 minutes (6MWTD) was longer in summiters (617 m) compared with nonsummiters (560 m; 95% CI, 7.6 to 106; P = .02). However, this significance was not maintained on a multivariate analysis performed to control for age, sex, and guide status (P = .08), leading to the conclusion that 6MWTD was not a robust predictor of summit success.This study did not show a correlation between postexercise oxygen saturation or 6MWTD and summit success on Denali.

Abstract

Heat-related illness is a common disease with significant morbidity and mortality. Despite no proven efficacy, application of chemical cold packs (CCP) to the skin overlying the large vessels of the neck, groin, and axillae is a traditional recommended cooling modality. The study objective was to compare the cooling rates of CCP applied to these traditional areas vs the glabrous skin surfaces of the cheeks, palms, and soles in exercise-induced hyperthermia.Ten healthy adult male volunteers walked on a treadmill in a heated room (40°±0.5°C) while wearing insulated military overgarments until their esophageal temperatures (Tes) reached 39.2°C. Each participant had three heat stress trials on separate days: no treatment followed by randomly ordered traditional (neck, groin, and axillae) cooling and glabrous skin cooling.With no treatment, Tes remained stable after the first 5 minutes of the heat trial (?Tes=0.12°±0.07°C/10 min). Traditional cooling followed a linear decline (?Tes=0.17°±0.04°C/10 min; P

Abstract

Mandated patient surveys have become an integral part of Medicare remuneration, putting hundreds of millions of dollars in funding at risk. The Centers for Medicare & Medicaid Services (CMS) recently announced a patient experience survey for the emergency department (ED). Development of an ED Fast Track, where lower acuity patients are rapidly seen, has been shown to improve many of the metrics that CMS examines. This is the first study examining if ED Fast Track implementation affects Press-Ganey scores of patient satisfaction.We analyzed returned Press-Ganey questionnaires from all ESI 4 and 5 patients seen 11AM - 1PM, August-December 2011 (pre-fast track), and during the identical hours of fast track, August-December 2012. Raw ordinal scores were converted to continuous scores for paired student t-test analysis. We calculated an odds ratio with 100% satisfaction considered a positive response.An academic ED with 52,000 annual visits had 140 pre-fast track and 85 fast track respondents. Implementation of a fast track significantly increased patient satisfaction with the following: wait times (68% satisfaction to 88%, OR 4.13, 95% CI [2.32-7.33]), doctor courtesy (90% to 95%, OR 1.97, 95% CI [1.04-3.73]), nurse courtesy (87% to 95%, OR 2.75, 95% CI [1.46-5.15]), pain control (79% to 87%, OR 2.13, 95% CI [1.16-3.92]), likelihood to recommend (81% to 90%, OR 2.62, 95% CI [1.42-4.83]), staff caring (82% to 91%, OR 2.82, 95% CI [1.54-5.19]), and staying informed about delays (66% to 83%, OR 3.00, 95% CI [1.65-5.44]).Implementation of an ED Fast Track more than doubled the odds of significant improvements in Press-Ganey patient satisfaction metrics and may play an important role in improving ED performance on CMS benchmarks.

Abstract

The Wilderness Medical Society (WMS) convened an expert panel to develop a set of evidence-based guidelines for the recognition, prevention, and treatment of heat illness. We present a review of the classifications, pathophysiology, and evidence-based guidelines for planning and preventive measures as well as best practice recommendations for both field and hospital-based therapeutic management of heat illness. These recommendations are graded on the basis of the quality of supporting evidence, and balance between the benefits and risks or burdens for each modality. This is an updated version of the original WMS Practice Guidelines for the Prevention and Treatment of Heat-Related Illness published in Wilderness & Environmental Medicine 2013;24(4):351-361.

Abstract

Participation in ultramarathon races and knowledge of these athletes continues to increase as the sport becomes more popular. Physicians and athletes need to better understand the impact of the unique aspects of ultramarathon races, such as race environment (temperature, humidity, and altitude), race distance, race stages, nutritional requirements and equipment, on athlete injuries and illness. Proper treatment of injuries and illnesses during an ultramarathon race is important for avoiding long-term medical issues. In this article, the evaluation and treatment of common musculoskeletal injuries and medical illnesses in ultramarathon runners are reviewed.

Abstract

An increasing participation in ultra-endurance foot races is cause for greater need to ensure the presence of appropriate medical care at these events. Unique medical challenges result from the extreme physical demands these events place on participants, the often remote settings spanning broad geographical areas, and the potential for extremes in weather conditions and various environmental hazards. Medical issues in these events can adversely affect race performance, and there is the potential for the presentation of life-threatening issues such as exercise-associated hyponatremia, severe altitude illnesses, and major trauma from falls or animal attacks. Organization of a medical support system for ultra-endurance foot races starts with a determination of the level of medical support that is appropriate and feasible for the event. Once that is defined, various legal considerations and organizational issues must be addressed, and medical guidelines and protocols should be developed. While there is no specific or universal standard of medical care for ultra-endurance foot races since a variety of factors determine the level and type of medical services that are appropriate and feasible, the minimum level of services that each event should have in place is a plan for emergency transport of injured or ill participants, pacers, spectators and event personnel to local medical facilities.

Abstract

Wilderness medicine is the practice of resource-limited medicine under austere conditions. In 2003, the first wilderness medicine fellowship was established, and as of March 2013, a total of 12 wilderness medicine fellowships exist. In 2009 the American College of Emergency Physicians Wilderness Medicine Section created a Fellowship Subcommittee and Taskforce to bring together fellowship directors, associate directors, and other interested stakeholders to research and develop a standardized curriculum and core content for emergency medicine (EM)-based wilderness medicine fellowships. This paper describes the process and results of what became a 4-year project to articulate a standardized curriculum for wilderness medicine fellowships. The final product specifies the minimum core content that should be covered during a 1-year wilderness medicine fellowship. It also describes the structure, length, site, and program requirements for a wilderness medicine fellowship.

Abstract

The purpose of the study was to evaluate the prevalence of acute kidney injury (AKI) during a multi-stage ultramarathon foot race. A prospective observational study was taken during the Gobi 2008; Sahara 2008; and Namibia 2009 RacingThePlanet 7-day, 6-stage, 150-mile foot ultramarathons. Blood was analyzed before, and immediately after stage 1 (25 miles), 3 (75 miles), and 5 (140 miles). Creatinine (Cr), glomerular filtration rate (GFR), and incidence of AKI were calculated and defined by RIFLE criteria. Thirty participants (76% male, mean age 40 + 11 years) were enrolled. There were significant declines in GFR after each stage compared with the pre-race baseline (p < 0.001), with the majority of participants (55-80%) incurring AKI. The majority of study participants encountered significant renal impairment; however, no apparent cumulative effect was observed, with resolution of renal function to near baseline levels between stages.

Abstract

Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners.This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot.One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25-40 years) and pack weight of 11 ± 1.8 kg (range, 8-16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future.Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction.

Abstract

The popularity of ultramarathon races continue to grow with runners participating in races throughout the world. These events offer challenges unique to an ultramarathon compared to a marathon race. These challenges require the athlete to focus on factors including race distance, race stages, race environment (temperature, humidity, and altitude), appropriate training, nutritional preparation, and equipment. Athletes ill prepared for these challenges will be at risk from injury and illness. The goal of this article is to review preventive strategies for managing commonly encountered musculoskeletal injuries and medical illnesses in ultramarathon runners.

Abstract

Heat illness is a common ailment that, if left untreated, is associated with high morbidity and mortality. Chemical cold packs (CCPs) and ice packs are widely used in the pre-hospital setting and by those with limited resources, yet no controlled studies have compared the cooling of ice to that of CCPs. This study determined the theoretical cooling of CCPs on a benchtop model, comparing the results to similarly sized ice packs, and is the first known comparison of these hyperthermia treatments.The CCPs used in Stanford University's Emergency Department were activated in an insulated volume of water (2 L), and temperature was recorded at 1-second intervals in a controlled environment (41°C at 20% humidity). The procedure was repeated with 1-quart ice packs.The CCPs resulted in a 5.25°C degree temperature drop, with a time constant (time to 63% of initial temperature--a common engineering characterization metric) of 1.72 minutes for the test volume. Ice packs resulted on average in a 19.8°C temperature change, with a time constant of 26.8 minutes. The CCPs provide less overall temperature change and were shorter lived. Application of 6 CCPs on a 50th percentile male (weight 86.6 kg, height 1.7 m), assuming ideal heat transfer, would result in less than 0.5°C temperature change. Similarly configured ice packs would result in a 2.5°C change.Experiments demonstrate that CCPs are inferior to similarly sized ice packs for thermal regulation, and lose their effectiveness more quickly. These findings support the consideration of ice packs as an alternative to chemical cold packs when cooling hyperthermic patients.

Abstract

High altitude headache (HAH) is the most common neurological complaint at altitude and the defining component of acute mountain sickness (AMS). However, there is a paucity of literature concerning its prevention. Toward this end, we initiated a prospective, double-blind, randomized, placebo-controlled trial in the Nepal Himalaya designed to compare the effectiveness of ibuprofen and acetazolamide for the prevention of HAH.Three hundred forty-three healthy western trekkers were recruited at altitudes of 4280 m and 4358 m and assigned to receive ibuprofen 600 mg, acetazolamide 85 mg, or placebo 3 times daily before continued ascent to 4928 m. Outcome measures included headache incidence and severity, AMS incidence and severity on the Lake Louise AMS Questionnaire (LLQ), and visual analog scale (VAS).Two hundred sixty-five of 343 subjects completed the trial. HAH incidence was similar when treated with acetazolamide (27.1%) or ibuprofen (27.5%; P = .95), and both agents were significantly more effective than placebo (45.3%; P = .01). AMS incidence was similar when treated with acetazolamide (18.8%) or ibuprofen (13.7%; P = .34), and both agents were significantly more effective than placebo (28.6%; P = .03). In fully compliant participants, moderate or severe headache incidence was similar when treated with acetazolamide (3.8%) or ibuprofen (4.7%; P = .79), and both agents were significantly more effective than placebo (13.5%; P = .03).Ibuprofen and acetazolamide were similarly effective in preventing HAH. Ibuprofen was similar to acetazolamide in preventing symptoms of AMS, an interesting finding that implies a potentially new approach to prevention of cerebral forms of acute altitude illness.